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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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Decision
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modification to roche elecsys folate ii immunoassay ROCHE DIAGNOSTICS CORP. k043318 12/23/2004
titanium mesh implant INTERPORE CROSS INTL. k041407 12/29/2004
visioplast acrylic resin TECRES k042414 12/29/2004
pmp4 oxy pro CARD GUARD SCIENTIFIC SURVIVAL, LTD. k043162 12/29/2004
phamatech quickscreen benzodiazepines test, models 9025, 9026, 9027t, 9153t and 9195x PHAMATECH INC. k043167 12/29/2004
modification to: zilver 635 biliary stent COOK, INC. k043481 12/29/2004
coronis 5mp medical flat panel display system BARCO NV BARCOVIEW k042221 12/30/2004
rightest blood glucose monitoring system BIONIME CORPORATION k042678 01/03/2005
horizon medical imaging MCKESSON MEDICAL IMAGING COMPANY k043146 01/04/2005
synthes (usa) electric pen drive system SYNTHES (USA) k043310 01/05/2005

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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